NCT05810298

Brief Summary

The aim of this study is to examine the effects of practicing pranayam (voluntary regulated breathing) and yogasana (standing poses of yoga) with subject education on vital capacity, respiratory muscle strength, spinal flexibility, body awareness, quality of life and nicotine dependence of smokers and non-smokers.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 22, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 2, 2023

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 23, 2023

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

March 30, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 12, 2023

Completed
Last Updated

April 12, 2023

Status Verified

March 1, 2023

Enrollment Period

2 months

First QC Date

March 30, 2023

Last Update Submit

March 30, 2023

Conditions

Keywords

YogaPranayamBreathing exerciseAsanaSmokingSpine healthSpinal stretches

Outcome Measures

Primary Outcomes (7)

  • Fagerström Test for Nicotine Dependence

    Nicotine dependence will be evaluated with this test

    4 weeks

  • Thoracic Spine Range of Motion

    Thoracic spinal elasticity will be evaluated with measuring rotational range of motion of T1-T2 spine using iPhone compass app. A strong and significant correlation was found between the Universel Goniometer and the Compass app by Furness et al. (2018), demonstrating good concurrent validity.

    4 weeks

  • Pulmonary Function Tests

    Medical International Research Spirodoc® Spiro spirometry will be used to evaluate pulmonary functions of volunteers.

    4 weeks

  • Respiratory Muscle Strength

    The Micro Medical Micro RPM respiratory pressure meter will be used to evaluate respiratory muscle strength.

    4 weeks

  • New York Posture Rating Chart

    Different parts of body will be screened by the physiotherapist and observation data will be used to evaluate volunteers posture.

    4 weeks

  • World Health Organization Quality of Life Assesment (WHOQOL-BREF)

    Turkish version of WHOQOL-BREF will be used in this study as given by WHO. This questionnaire will be used to provide numerical data on Quality of Life assesments of the volunteers.

    4 weeks

  • Body Awareness Questionnaire(BAQ)

    Body Awareness Questionnaire(BAQ) will be used to provide numerical data on subjects body awareness. A Turkish validity study of BAQ was performed by Karaca and it's valid as well as reliable.

    4 weeks

Study Arms (2)

Smokers Group

EXPERIMENTAL

Education about smoking Asana practice (Only standing yoga poses with rhytmic breathing) Pranayam (Rhytmic regulated breathing)

Other: Asana PracticeOther: Pranayam Practice (Rhythmic regulated breathing)Behavioral: Smoking Education Program

Control Group

ACTIVE COMPARATOR

Asana practice (Only standing yoga poses with rhytmic breathing) Pranayam (Rhytmic regulated breathing)

Other: Asana PracticeOther: Pranayam Practice (Rhythmic regulated breathing)

Interventions

Yogasana training will be comprised of active movements when standing. Spine and limbs stretches eccentrically respecting the movement patterns of body without pushing limits. Transition in between poses will be synchronized with breathing pattern in zero resistance flow. The exercises will be done 2 days a week online under the supervision of physiotherapist. Total duration of standing poses training will last for 4 weeks.

Control GroupSmokers Group

Breathing exercises will be comprised of diaphragmatic breathing, holding the breath after inhaling deeply and exhaling passively or exhaling actively by contracting abdominal muscles and inhaling passively. The exercises will be done 2 days a week online under the supervision of physiotherapist. Total duration of breathing exercises will last for 4 weeks.

Control GroupSmokers Group

The aim of the education is to increase awareness of subjects who are chronical smokers. The subject education will be performed at least once via face to face interview. Education topics will be covered basic information about harmful effects of habitual smoking and how to reduce the side effects of nicotine withdrawal.

Smokers Group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Voluntary participation in research
  • Young healthy subjects who were aged between 18-60 years with or without daily cigarette smoking habit

You may not qualify if:

  • Allergic disorders or respiratory disorders
  • History of a major surgery in the last 2 years
  • Neurological diseases
  • Cardiovascular diseases which are contraindicates exercise
  • Fractures or orthopedic problems in upper or lower extremities
  • Systemic rheumatical diseases(Rheumatoid Arthritis, Ankylosing Spondilitis etc.)
  • Systemic diseases and respiratory disorders will be ruled out in the selected subjects by taking their detailed history and by their thorough clinical examination by the researcher.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fizyoram Physiotherapy Counseling Center

Istanbul, 34517, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Smoking

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2023

First Posted

April 12, 2023

Study Start

December 22, 2022

Primary Completion

March 2, 2023

Study Completion

March 23, 2023

Last Updated

April 12, 2023

Record last verified: 2023-03

Locations